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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Intersept Tubing Packs

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  Class 2 Device Recall Medtronic Intersept Tubing Packs see related information
Date Initiated by Firm November 19, 2012
Date Posting Updated December 28, 2012
Recall Status1 Terminated 3 on April 04, 2013
Recall Number Z-0618-2013
Recall Event ID 63769
510(K)Number K800178  K891687  K012538  K113845  
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
Product Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers:

0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1.

Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432

Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.

Code Information Pack Model Pack Lot, 0E27R16- 11239917, 11252800, 11264666;, 1A30R6- 12132577, 12219267;, 2493R24- 11187015, 11199707, 11224309, 11227205, 11556735;, 2493R25- 11646941, 11713200, 11745242, 11813334, 11852673, 11886412, 11990393, 12033630, 12114699, 12178107, 12191642, 12450856;, 5D56R5- 11298229, 11357085, 11465358, 11541270, 11601193, 11654853, 11702415, 11745232, 11766305, 11822320, 11838721, 11852677, 11930380, 12024708, 12166379, 12292156;, 5Z93R4- 11713132, 11736880, 11749958, 11766283, 11808651, 11860604, 11878689, 11911068, 11948473, 5Z93R5- 12236493;, 12411746, 7E64R2- 11933798;, 7J53R2- 12172725;, 7M13R1- 12168157;, 7M14R1- 12349772;, 7N16R- 12349786;, 7P25R1- 12327801, 12449801, 12457250;, 7P93R1- 12349795, 12374420;, 7Q11R1- 12344028, 12456303;, BB7L63R2- 12408737;, BB7N26R- 12312571;, CB5174R11- 11293051, 11315344, 11334856, 11489271, 11745162, 11886341, 11977682, 12019852, 12062713, 12098852, 12139621, 12146752, 12258941, 12277502, 12326468, 12421465, 206110946; , CB5175R13- 11292866, 11334859, 11432873, 11442937, 12182778, 12411655; , CB5Q03R6- 11713162, 11766245, 11787583, 11923139, 11934952; , CB5Q03R7- 12114626;, CB6C53R6- 12423767;, CB7C15R2- 12411647;, CB7C59R2- 11731501;, 11813316, 11838743, 11869767, 11908794, 11982413, 12019907, 12146796, 12151706, 12201727, 12292133, 12423702;, CB7C60R2- 11687047, 11724030, 11843434, 11878672;, CB7C74R2- 11895167;, CB7D91R5- 11961280, 12130493, 12146882, 12191604, 12277455, 12411687, 12423760; , CB7E35R2- 11839101; , CB7E38R1- 11843886, 11885844, 11990360, 12105025, 12133083, 12159400; , CB7G21R4- 12032413, 12033728, 12040524, 12083359, 12360622; , CB7L48R1- 12301694;, CB7L72R1- 12155258;, CB7P82R1- 12440601;, HY6U96R2- 206133995;, HY6Y52R2- 11826276;, HY7E87R1- 11830948, 11898103, 11923498, 12323794, 12435409;, SS7J91R3- 12175428;, SSCB7L48R- 12120109;, SSTL7G78R1 -11986264;, TL5S33R7- 12093478;, 12139612, 12172589, 12315375; , TL6V77R1- 11217931, 11260111; , TL7B51R1- 11559097, 11622968, 11664762, 11687063, 11712834; , TL7G20R3- 12258680, 12271138, 12360554, TL7G78R3- 12067309;, TL7R87R1- 206114578, 206145379.
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
For Additional Information Contact
763-526-6000
Manufacturer Reason
for Recall
Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility.
FDA Determined
Cause 2
Package design/selection
Action Medtronic sent a "Urgent Medical Device Customer Notification" letter dated November 19, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected product and to return affected product, but if they have concerns about replacement than they recommend to inspect and return any damaged product.. For further questions please contact your local Medtronic sales representative or Lifeline Technical Services at 1-877-526-7890. Outside the US, please call 1+763-526-7890. We apologize for any inconveniences this issue may have caused you or your institution.
Quantity in Commerce 1552
Distribution Worldwide Distribution--USA (nationwide) including the states of AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of CANADA and MALAYSIA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DWF and Original Applicant = EXTRACORPOREAL MEDICAL SPECIALITIES, INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC BLOOD SYSTEMS, INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC INC.
510(K)s with Product Code = DWF and Original Applicant = MEDTRONIC VASCULAR
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